Screening for Barrett’s esophagus: accuracy of exhaled breath analysis using an electronic nose device
- Conditions
- Barrett's esophagus
- Registration Number
- NL-OMON21425
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 980
Aged 18 years or older
-Undergoing a clinically indicated (surveillance) endoscopy
-Able to give signed informed consent
1.Patients with known BE (defined as =1 cm of columnar mucosa with histopathologic confirmation of intestinal metaplasia without dysplasia)
2.Individuals with GERD symptoms without BE (GERDQ-score =8 or the endoscopic presence of reflux esophagitis)
3.‘Healthy’ controls without BE or GERD
-Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC))
-Prior surgical esophageal or gastric resection or prior ablative therapy
-Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled breath
Withdrawal criteria after initial study inclusion:
Patients can be withdrawn from the study if:
-Incomplete upper endoscopy
-Active H. Pylori infection
-BE segment <1cm or no intestinal metaplasia in the esophagus
-Intestinal metaplasia in the stomach
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the eNose for detecting BE with the diagnosis made by upper endoscopy as the reference standard.
- Secondary Outcome Measures
Name Time Method -Acceptance rates for breath testing <br>-Patient acceptability of the eNose procedure<br>-Technical or patient related problems obtaining a read-out from the Aeonose™<br>-Accuracy of the eNose with which it could distinguish patients with BE from patients with GERD<br>-Reproducibility by repeated testing<br>-Effect of PPI use on the accuracy of the eNose for detecting BE<br>